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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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NA - 05415067034960

Clinician Programmer App
ST. JUDE MEDICAL, INC.
55600
In Commercial Distribution

  • 05415067034960 ()
55600

  • Multiple active implantable device programmer

NeuroSphere™ - 05415067050311

Digital Health App
ADVANCED NEUROMODULATION SYSTEMS, INC.
3876
In Commercial Distribution

  • 05415067050311 ()
3876

  • Multiple active implantable device programmer

DreamMapper - 00606959057692

DreamMapper App iOS
Respironics, Inc.
DreamMapper iOS, North American Instance - 2
In Commercial Distribution

  • 00606959057692 ()
1101478

  • Self-care monitoring/reporting software

Viewfinder remote app - 00690103215847

Viewfinder remote app
Edwards Lifesciences LLC
VFREM
In Commercial Distribution

  • 00690103215847 ()
VFREM

  • Bedside monitor remote-viewing software, physiological parameter
  • General-purpose multi-parameter bedside monitor

CONNEXX - 05714880187229

APP CONNEXX FIT2GO
Ws Audiology Usa, Inc.
Connexx Fit2Go
In Commercial Distribution

  • 05714880187229 ()
21023158

  • Audiometric/hearing device software

Onduo - 00860000249539

Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software

Onduo - 00860000249522

Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software

Widex - 05706069659689

BEYOND app iOS
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069659689 ()
5 300 0003 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

Widex - 05706069599985

COM-DEX app Android
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599985 ()
5 300 0001 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

Widex - 05706069599978

COM-DEX app iOS
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599978 ()
5 300 0000 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

Broomwell - 00851074007293

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007293 ()
RX22773-004

  • Telemetric electrocardiographic ambulatory recorder

AMI - 00851074007255

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007255 ()
RX22773-002

  • Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007248

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder

AMI - 00851074007231

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007231 ()
RX22711-002

  • Telemetric electrocardiographic ambulatory recorder

CardioLabs - 00851074007224

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007224 ()
RX22711-001

  • Telemetric electrocardiographic ambulatory recorder

Cardiostaff - 00851074007194

Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007194 ()
RX22773-003

  • Telemetric electrocardiographic ambulatory recorder

Cardiostaff - 00851074007170

Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007170 ()
RX22711-003

  • Telemetric electrocardiographic ambulatory recorder

hear.com - 05714880113228

APP HEAR.COM HORIZON
Ws Audiology Usa, Inc.
hear.com horizon
In Commercial Distribution

  • 05714880113228 ()
10996569

  • Hearing aid/implant system remote control

GN Hearing - 05708296196746

APP,GN SMARTAPP
Gn Hearing A/S
21607300
In Commercial Distribution

  • 05708296196746 ()


  • Hearing aid/implant system remote control

Eloquence - 00816486021237

Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer
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